Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus
Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.
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US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma
The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.
Positive Feelings About Negative Controls: US FDA Explores Another Tool For The Real-World Evidence Toolbox
CDC precedents and PDUFA VII commitments could help advance the robustness of observational studies based on real-world data.